REVIEWER
REVIEWER
Posted on :
20-01-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Title: REVIEWER
Job Location: Bengaluru Karnataka India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Title: REVIEWER
Date: 26 Dec 2024
Job Location: Bangalore
Pay Grade
Year of Experience:
Job Description
Designation: Assistant Manager
Job Location: Bangalore
Department: QUALITY ASSURANCE COMMON SMALL MOLECULES
About Syngene
Incorporated in 1993 Syngene International Ltd. is an innovationfocused global discovery development and manufacturing organization providing integrated scientific services to the pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as BristolMyers Squibb Baxter Amgen GSK Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240 strong team of scientists who work with clients from around the world to solve their scientific problems improve R&D productivity speed up time to market and lower the cost of innovation.
Job Purpose
QA Reviewer Management Information Data
Job Description
Job Description:
Technical/functional Skills
Behavioural Skills
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law. In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Date: 26 Dec 2024
Job Location: Bangalore
Pay Grade
Year of Experience:
Job Description
Designation: Assistant Manager
Job Location: Bangalore
Department: QUALITY ASSURANCE COMMON SMALL MOLECULES
About Syngene
Incorporated in 1993 Syngene International Ltd. is an innovationfocused global discovery development and manufacturing organization providing integrated scientific services to the pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as BristolMyers Squibb Baxter Amgen GSK Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240 strong team of scientists who work with clients from around the world to solve their scientific problems improve R&D productivity speed up time to market and lower the cost of innovation.
Job Purpose
QA Reviewer Management Information Data
Job Description
Job Description:
- Review of Management Information data and Key performance indicators for Small Molecule Quality.
- Pharmaceutical quality Data analysis interpretation trending visualization and presentation of Quality data using IT tools like Power BI Power Point presentations Excels AI tools.
- Tracking and driving action plan for red KPIs and quality risks.
- Strategic initiative data analysis and Trending of small molecule quality data.
- To drive and support quality excellence programs in quality function.
- Implementation of Lean six sigma 5S and Kaizens.
- Communicate promptly and effectively with the clients and Crossfunctional team members.
- QMS investigations root cause analysis and QMS Trending.
- Corrective and Preventive action (CAPA) identification implementation and effectiveness monitoring.
- Change control management and effectiveness of change management.
- Preparation and Review of GMP documents like Quality agreements Site Master File (SMF) Quality Manual Master Validation Plan.
- Quality risk management and risk assessments.
- To face customer/third party cGMP audits regulatory audits and internal quality audits. Audit response writing and CAPA plan.
- Vendor audits and vendor management. Qualification of contract testing laboratory.
- Preparation and review of SOPs protocols schedules audit responses and other GMP documents in EDMS.
- Review of Equipment qualification and Computer system validation (CSV) documents.
- Implement improvement ideas and appropriate measures to reduce Nonconformances and to increase efficiency and productivity.
- Effective implementation of selfinspection program to ensure zero observation in the internal and external audits.
- Handling of Management Information data and monitoring of Key performance indicators for Small Molecule Quality.
- Tracking and driving action plan for red KPIs and quality risks.
- To drive and support quality excellence programs in quality function.
- Implementation of Lean six sigma 5S and Kaizens.
- Communicate promptly and effectively with the clients and Crossfunctional team members.
- QMS investigations root cause analysis and QMS Trending.
- Change management and risk assessments.
- Vendor audits and vendor management. Qualification of contract testing laboratory.
- Preparation and Review of GMP documents like Quality agreements Site Master File (SMF) Quality Manual Master Validation Plan for Small Molecule quality.
Technical/functional Skills
- Experience in Pharmaceutical Quality control Quality assurance and manufacturing (API Formulations Injectables).
- Excellent English Language proficiency and good communication skills.
- Excellent in Information Technology tools like Power BI Power Point presentations Excels AI tools.
- Presentation skills and data interpretation.
- Pharmaceutical Quality Data analysis and trending.
- Well versed with EQMS Trackwise and EDMS applications.
- Well versed with analytical laboratory softwares like LIMS Chromeleon and Empower softwares.
- Qualified QMS investigator and Trainer.
- Qualified auditor as per ISO 9001 or equivalent.
Behavioural Skills
- Strong commitment towards work and a high level of dedication enthusiasm motivation and persuasive ability in a team.
- Good speakinglisteningwriting skills attention to details proactive selfstarter.
- Ability to work successfully in a dynamic ambiguous environment.
- Ability to meet tight deadlines and prioritize workloads.
- Ability to develop new ideas and creative solutions.
- Should be able to work in team and flexible for working in shifts.
- Should be a focused employee.
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law. In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
/jobs/view/02d186232a27f1ee55ef8657e2909ae2
Employment Type
Full Time
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
